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FDA 510(k)

UNITY TOATAL KNEE SYSTEM

K-Number: K113060 · 2012-09-10

ApplicantCorin USA
Decision Date2012-09-10
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITY TOATAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2012-09-10 under 510(k) number K113060. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITY TOATAL KNEE SYSTEM?

UNITY TOATAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-10. The listed applicant is Corin USA. The 510(k) number is K113060.

When did UNITY TOATAL KNEE SYSTEM receive FDA 510(k) clearance?

UNITY TOATAL KNEE SYSTEM received FDA 510(k) clearance on 2012-09-10, under 510(k) number K113060.

Who is the listed applicant for UNITY TOATAL KNEE SYSTEM?

The FDA 510(k) record lists Corin USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNITY TOATAL KNEE SYSTEM?

The FDA product code for UNITY TOATAL KNEE SYSTEM is JWH.

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Related Devices (Code: JWH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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